Heart Diseases, Rhythm; Abnormal
Conditions
Keywords
Holter ECG recording
Brief summary
Collection of Holter surface ECGs for the development of new sensing and detection algorithms
Detailed description
The aim of the study is to collect data from surface ECGs by using Holter ECG recordings from patients with different forms of diagnosed arrhythmias and/or specific ECG characteristics from heart diseases to support the development of new sensing and detection algorithms for implants.
Interventions
DIAGNOSTIC_TEST3-channel Holter ECG recording
3-channel Holter ECG recording for patients undergoing an EPS
DIAGNOSTIC_TEST12-channel Holter ECG recording
12-channel Holter ECG recording for patients undergoing a routine follow-up
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is able to understand the nature of the study and willing to provide written informed consent. * Patient is willing and able to attend Holter ECG procedure following a visit * History of at least one of the following conditions (established via ECG prior to enrollment): (A) Patient with pacemaker/ICD and 1. Ventricular stimulation \> 30 % or (B) Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and at least one of the following: 2. Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus) or 3. Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) syndrome or 4. Atrioventricular Nodal Reentrant Tachycardia (AVNRT) or 5. Sinus Tachycardia at rest or 6. Atrial Flutter or 7. Any form of Ventricular Tachycardia (VT) or 8. Silent/Paroxysmal/persistent/permanent AF or 9. Brugada syndrome or 10. Long QT syndrome or 11. Right Bundle Branch Block (RBBB) or 12. Left Bundle Branch Block (LBBB) or 13. Myocardial Ischemia/Acute Myocardial Infarction or 14. Other abnormal QRS(T) complex, ST segment or T-wave morphology, i.e. any other QRS anomaly / ST segment elevation / ST segment Depression / T wave changes
Exclusion criteria
* Any condition which precludes the patient's ability to comply with the study requirements. * Known allergy to patch electrodes. * Pregnant or breast feeding. * Less than 18 years old. * Participation in another interventional clinical investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successful ECG Recordings Per Condition | 24 hours | All ECG recordings were evaluated by an internal board and all patients were allocated to one of 15 groups (covering 14 ECG patterns of interest and one group for no ECG pattern of interest recorded). |
Countries
Germany
Baseline characteristics
| Characteristic | Total | — |
|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 17.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 89 participants | — |
| Sex: Female, Male Female | 33 Participants | — |
| Sex: Female, Male Male | 56 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 23 |
| other Total, other adverse events | 1 / 66 | 5 / 23 |
| serious Total, serious adverse events | 3 / 66 | 0 / 23 |
Outcome results
Primary
Number of Successful ECG Recordings Per Condition
All ECG recordings were evaluated by an internal board and all patients were allocated to one of 15 groups (covering 14 ECG patterns of interest and one group for no ECG pattern of interest recorded).
Time frame: 24 hours
Population: According to the statistical analysis plan it was pre-specified to report the number of successful Holter recordings per ECG pattern for all patients irrespective of the method for Holter recording.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient With Pacemaker/ICD and Vp > 30% | Number of Successful ECG Recordings Per Condition | 6 Successful ECG recordings |
| Frequent Ventricular Extrasystoles (VES) (Incl. Bigeminus) | Number of Successful ECG Recordings Per Condition | 12 Successful ECG recordings |
| Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) Syndrome | Number of Successful ECG Recordings Per Condition | 4 Successful ECG recordings |
| Atrioventricular Nodal Reentrant Tachycardia (AVNRT) | Number of Successful ECG Recordings Per Condition | 7 Successful ECG recordings |
| Sinus Tachycardia at Rest | Number of Successful ECG Recordings Per Condition | 7 Successful ECG recordings |
| Atrial Flutter | Number of Successful ECG Recordings Per Condition | 8 Successful ECG recordings |
| Any Form of Ventricular Tachycardia | Number of Successful ECG Recordings Per Condition | 11 Successful ECG recordings |
| Silent/ Paroxysmal/ Persistent/ Permanent Atrial Fibrillation (AF) | Number of Successful ECG Recordings Per Condition | 10 Successful ECG recordings |
| Brugada Syndrome | Number of Successful ECG Recordings Per Condition | 3 Successful ECG recordings |
| Long QT Syndrome | Number of Successful ECG Recordings Per Condition | 0 Successful ECG recordings |
| Right Bundle Branch Block (RBB) | Number of Successful ECG Recordings Per Condition | 5 Successful ECG recordings |
| Left Bundle Branch Block (LBB) | Number of Successful ECG Recordings Per Condition | 5 Successful ECG recordings |
| Myocardial Ischemia/ Acute Myocardial Infarction | Number of Successful ECG Recordings Per Condition | 3 Successful ECG recordings |
| Other Abnormal QRS(T) Complex, ST Segment or T-wave Morphology | Number of Successful ECG Recordings Per Condition | 4 Successful ECG recordings |
| No ECG Pattern of Interest Recorded | Number of Successful ECG Recordings Per Condition | 4 Successful ECG recordings |